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科濟藥業-B(02171)將於2021年ESMO大會上呈列CT041研究進展口頭報吿
格隆匯 07-28 23:04

格隆匯7月28日丨科濟藥業-B(02171)公吿,公司董事會將於2021年歐洲腫瘤內科學會大會(2021年ESMO大會)以口頭報吿形式呈列發佈CT041(一種靶向CLDN18.2自體CAR-T候選產品)研究者發起的試驗的進展,歐洲腫瘤內科學會大會為一個具影響力的歐洲腫瘤學平台,為來自世界各地的臨牀醫生、研究人員、患者倡議者、記者及醫療行業代表而設計。該研究進展的摘要將於2021年9月18日零時五分及口頭報吿呈列材料將於2021年9月19日(為2021年ESMO大會舉行時間)及於公司網站www.carsgen.com相應公佈。

CT041是一種潛在全球同類首創的、靶向CLDN18.2自體CAR-T候選產品,經開發用於治療CLDN18.2陽性實體瘤,主要治療胃癌╱胃食管結合部癌及胰腺癌。截至本公吿之日,CT041為全球唯一靶向CLDN18.2的且已獲得美國FDA和國家藥監局的IND批准並正在進行臨牀試驗研究的CAR-T細胞免疫治療方法。CT041在正在進行的臨牀試驗中表現出前景光明的治療效果及良好的安全性。公司認為,CT041有可能在未來成為胃癌和胰腺癌的骨幹療法並惠及全球大量患者羣體。

除了在中國的研究者發起的試驗外,公司還在中國啟動了一項針對晚期(不可切除或轉移性)胃癌╱胃食管結合部癌和胰腺癌的Ib/II期臨牀試驗,以及在美國啟動了一項針對晚期(不可切除或轉移性)胃癌或胰腺癌的Ib期臨牀試驗。CT041於2020年獲得美國FDA授予孤兒藥認定,用於治療胃癌╱胃食管結合部癌,並於2021年獲得EMA授予孤兒藥產品認定,用於治療胃癌。公司已在中國向國家藥監局申請啟動關鍵II期臨牀試驗所需的監管批准。公司亦擬於2022年在美國進行一項關鍵II期臨牀試驗。

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